Clinical Trials

As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit.

Missing category name

PILGRIM

Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
NCT03765528

Impact of Prescription Quality, Infection Control and Antimicrobial Stewardship on Gut Microbiota Domination by Healthcare-Associated Pathogens

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

To determine the differential impact of inappropriate antibacterial prescription compared to adequate or no antibacterial prescription on intestinal microbiota domination by EPE or VRE or infection with C. difficile

Secondary Outcomes

  • To determine the rate of in-hospital vs. pre-admission intestinal colonization with EPE, VRE, and/or C. difficile
  • To determine the rate of in-hospital vs. pre-admission intestinal domination by EPE, VRE, or C. difficile infection
  • To determine inter-rater reliability of interdisciplinary AMS specialists rating antibacterial prescription appropriateness
  • To identify behavioral determinants and knowledge gaps leading to inappropriate antibacterial prescriptions
  • To assess the acceptance rate of AMS Board ratings by the physicians participating in the qualitative study
  • To assess correlation of appropriate antibacterial prescription with quality indicators of AMS implementation
  • To identify risk factors for colonization, intestinal domination, and infection by EPE, VRE and C. difficile, including comorbidities and drugs known to disrupt the intestinal microbiota, and high-risk bacterial clones prone to dominate the microbiota due to high fitness

Diagnosis

  • Infectious diseases: Others

Target population

Age

18-

Inclusion criteria

  • Age ≥ 18 years
  • Planned treatment or high likelihood of any systemic antibacterial treatment except trimethoprim/sulfamethoxazole within the next 10 days for a duration of ≥ 5 days
  • Patients able to provide a stool sample before or within 4 hours of receiving first antibiotic dosage
  • Written informed consent provided prior to inclusion.

 

Exclusion criteria

  • Patients who have received courses of systemic antibacterials for 7 days or more within the past two months
  • Patients having received any antibacterial compound other than trimethoprim/sulfamethoxazole within 14 days prior to study enrolment except first antibiotic dosage within 4 hours prior enrolment
  • Patients with diarrhea at enrolment (≥3 unformed bowel movements within 24h)
  • Patients with a stoma (jejunostomy, ileostomy, or colostomy) at time of inclusion
  • Patients on enteral (tube fed or PEG) or parenteral nutrition
  • Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge
  • Patients exclusively treated as outpatients without prior hospital admission
  • Patient has previously participated in this study

Study design

  • Multicenter
  • Prospective
  • Cohort

Miscellaneous

There will be no invasive measures, incl. no additional blood samples. During the course of the study, stool samples will be collected.

Documents (password protected)

Go to download area

Responsibilities in overall study

(National) Coordinating Investigator

Univ.-Prof. Dr. med. Jörg Janne Vehreschild

Project management

Infektiologie II

Dr. rer. medic. Kerstin Albus
Dr. med. Annika Claßen (geb. Löhnert)